FOI release

MHRA FOIA Request Disclosure Log 1 October - 31 December 2020

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REF SUBJECT RESPONSE SENT RESULT
FOI 20/396 01/10/2020 I would like to make a FOI request for any information you may hold in relation to toxicity/teratogenicity testing results for Dicyclomine and Doxylamine in combination (without Pyridoxine). 16/10/2020 Disclosed in part
FOI 20/394 02/10/2020 Electronic copies of the CTA submission package (e.g. study protocol, investigator brochure) received by MHRA in relation to the Inarigivir Phase 2 clinical study (EudraCT no: 2019-000896-17). All appropriately redacted to remove any personal or data protection material. 2. Electronic copies of all correspondence received/sent by MHRA in relation to the Inarigivir Phase 2 clinical study (EudraCT no: 2019-000896-17). All appropriately redacted to remove any personal or Data Protection material 29/10/2020 Disclosed in part
FOI 20/397 05/10/2020 1. Where could I find out how many doses of vaccines have been administered during the last decades? 2. Are there any reports published by the MHRA regarding the suspected ADR reports and the subsequent investigations into associated fatal and/or serious outcomes? 3. Is there any way to find out what Yellow Card reports have led to awards paid out by the Vaccine Damage Payment Scheme? Are they any reports published by the Vaccine Damage Payment Scheme Does such a statistic exist for the Yellow Card6. What is the penalty for doctors or medical staff who do not fill out a Yellow Card report following a vaccine-associated adverse event? system? 02/11/2020 Disclosed in full
FOI 20/399 08/10/2020 Under the freedom of information act I would like to see all the safety tests you have available for the vaccines on the childhood immunization schedule? Tests-independent from those run by the pharmaceutical companies, of course. Please send me the data at your earliest convenience. 05/11/2020 Disclosed in part
FOI 20/400 08/10/2020 Teva UK Limited are writing to request a copy of the educational material associated with Perrigo UK Sildenafil 50 mg Pharmacy Product as follows: • Essential information for the supply of Sildenafil 50 mg Film Coated Tablets (P) • Pharmacy Checklist for Sildenafil 50 mg Film Coated Tablets (P) 21/10/2020 Disclosed in full
FOI 20/401 08/10/2020 I would be grateful for a list of the suspected adverse reaction yellow card scheme reports associated with e-cigarettes or e-liquids from 2019 and from January 1 2020 to October 1 2020, with a breakdown of the symptoms or illness associated with the reported events. 05/11/2020 Disclosed in full
FOI 20/403 10/10/2020 Dear Sirs thank you for the two reports. However there appears to have been an inspection performed by Andrew Bill in September 2002, see references to previous inspections in the 2003 report by Zoe Nelson. Please could you provide a copy of the missing inspection report please 06/11/2020 Disclosed in part
FOI 20/405 12/10/2020 I would like to see a copy of the latest report of the MHRA for Joint Committee on Vaccination and Immunisation: VACCINE-ASSOCIATED SUSPECTED ADVERSE REACTIONS REPORTED VIA THE YELLOW CARD SCHEME: Adverse reactions to Vaccines. Could you send me a copy? 15/10/2020 Disclosed in full
FOI 20/406 12/10/2020 Please provide all product licences, including licences of right, granted for Hormone Pregnancy Tests (HPTS), and any related correspondence, to the following companies: • Roussel for the products Amenorone Forte and Mornone • Organon for the product Menstrogene • British Schering (later Nicholas Laboratories Ltd) for the product Orasecron • Parke Davis for the products Morlutin A and Morlestrin • Duncan Flockhart for the products Secrodyl • Wallis Manufacturing Chemists Ltd for the products Paralut • Marshalls Pharmaceuticals Ltd for the product Pregornot 29/10/2020 Disclosed in part
FOI 20/407 15/10/2020 Would it be possible to retrieve all correspondences (with attachments) between the MHRA and the manufacturer of the product Engerix-B (at those times SmithKlineBeecham or Smith Kline and French) related to the addition of demyelinating diseases (optic neuritis, multiple sclerosis, transverse myelitis) to the summary of product characteristics (SMPC) I suppose those correspondences occured between 1988 and 1994. If any other document (pharmacovigilance reports / meeting notes / CCDS / Core Safety Information...) are related to discussions / assesment of MS/ON/TM cases occuring after an HepB vaccination in the late 80's / early 90's (not after 1994), please include those into the current FOI request. 26/10/2020 Not held
FOI 20/409 15/10/2020 The number of whistle blower reports you have received over the last five years broken down by category (i.e the categories you use internally to classify whistle blower reports) 11/11/2020 Disclosed in full
FOI 20/410 15/10/2020 Risk Management Plan (RAM) 27/10/2020 Disclosed in part
FOI 20/411 16/10/2020 The full protocol for the AstraZeneca Clinical Trial for the COVID-19 vaccine (ADZ1222) 28/10/2020 Not held
FOI 20/412 19/10/2020 On 30th July you enabled an assay called the AbC-19 Rapid Test to receive a CE mark for professional use. On what grounds was this test cleared? What were the communications you received regarding the test in the period between its submission and clearance? 22/10/2020 Not held
FOI 20/413 16/10/2020 BAME in Finance 09/11/2020 Disclosed in full
FOI 20/414 19/10/2020 Gelstix adverse incident reports - Further to our previous request, please can you confirm whether any adverse incident reports been made in respect of this product? Any further information or details would be gratefully received 11/11/2020 Disclosed in full
FOI 20/416 19/10/2020 Can you provide me information on fake drugs that got in to the uk market. including prescription and over the counter drugs. also ones that got in to the NHS. 11/11/2020 Disclosed in full
FOI 20/417 21/10/2020 Could we get an RMP of any such reclassification application? 04/11/2020 Disclosed in full
FOI 20/418 19/10/2020 Could a reports Of the trials and of of the adverse damages reported in clinical trials with all front runner vaccines to be disclosed To be at your earliest convenience 13/11/2020 Not released
FOI 20/419 23/10/2020 Would it be possible to obtain information on the numbers and quantities of Xanax/alprazolam seized/confiscated/interdicted by the MHRA in each of the following years - 2014, 2015, 2016, 2017, 2018, 2019, 2020 - please? 11/11/2020 Disclosed in part
FOI 20/420 26/10/2020 I would like to request data from the Yellow Card Scheme on: 1. number of deaths from fire/burns relating to emollient skin creams (both paraffin-based and paraffin-free) from 1st Jan 2010 to now, split monthly in a csv file; 2. number of other adverse events/injuries from fire/burns relating to emollient skin creams (both paraffin-based and paraffin-free) from 1st Jan 2010 to now, split monthly in a csv file;) 20/11/2020 Disclosed in full
FOI 20/421 26/10/2020 can you please provide any information/record that MHRA holds in regards to the safety evidence to support the use of the following excipients within vaccines. a) mercury or thimerosal b) aluminum c) animal cell strains (animal viruses have crossed over to humans causing cancer [simian virus]) d) polysorbate 80 e) aborted fetus cells 23/11/2020 Disclosed in full
FOI 20/423 29/10/2020 I would like to request the final Pharmacovigilance inspection reports from the last inspections (final inspection reports) for GSK and Astra Zeneca. 24/11/2020 Disclosed in part
FOI 20/425 02/11/2020 As per RFI query no.2 under the heading RMP for our ongoing MAA-Lenalidomide Capsules-PL 12762/0637-0643 for UK, MHRA has requested us to add follow-up questionnaire for tumour flare reaction in line with the originator. Additionally, we would also like to update the currently available follow up forms for risk of “Serious infection due to neutropenia” and “Secondary primary malignancies” in-line with the originator. However, these f/u forms are not publicly available, hence we would like to request you to kindly provide copy of these f/u questionnaires for the below risks. Tumour flare reaction; Serious infection due to neutropenia; Secondary primary malignancies 04/11/2020 Disclosed in full
FOI 20/426 02/11/2020 I would like to file a freedom of information request for these documents. The MCA assessment reports used in the authorisation of the 0.4mg (October 1999) and 0.8mg (April 2001) doses of Lipobay/cerivastatin. Bayer report on the risks of Lipobay/cerivastatin sent to MCA on 18 June 2001, and the MCA's analysis of this report 26/11/2020 Not released
FOI 20/427 02/11/2020 I would be most grateful if you would provide me, under the Freedom of Information Act, details in respect to the contract below. Multi-Domain Master Data Management Platform. 01/12/2020 Disclosed in full
FOI 20/429 30/10/2020 ADRs Teva branded Levothyroxine (lactose free) 27/11/2020 Disclosed in part
FOI 20/430 27/11/2020 British Cannabis: Bulk CBD Cannabis Extracts - British Cannabis Are claiming MHRA registration. Could you confirm whether this is the case please? I have not found them on your register of wholesalers or manufacturers. 04/12/2020 Not released
FOI 20/431 03/11/2020 Please can you provide me with the results of the AstraZeneca vaccine trials 1 and 2 for their covid 19 vaccine that have taken place and can you confirm that in the trials that a saline placebo has not been used? 30/11/2020 Disclosed in full
FOI 20/432 03/11/2020 IF the original product licence was The original product licence (PL 00039/0412) was granted on 17 December 1992, as an abridged simple (Article 10c) application, what was: the basis of approval for the reference product used to support the informed consent / simple abridged 10 c application. Was this product in the UK or EU. It would make sense you don’t have any clinical data as it was a 10 c application, can I get the data from the reference product please? 20/11/2020 Disclosed in full
FOI 20/433 04/11/2020 SHOT/SABRE reports 2018 05/11/2020 Disclosed in full
FOI 20/436 05/12/2020 Please disclose the following: All relevant documents proving that all Medicines and Healthcare product Regulatory Agency (MHRA) approved vaccines have been tested for quality and relevant documents proving the safety and effectiveness of vaccines over the period between 01 January 2000 through 31 October 2020. If the referenced period is prohibitive, please provide the relevant documents for the period between 01 October 2019 and 31 October 2020. 04/12/2020 Disclosed in full
FOI 20/437 26/10/2020 Information request for electronic copies of the non-clinical/clinical expert reports for the Cyclogest 200mg and 400mg licences mentioned above. The UK national licences for Cyclogest were approved in the UK for both strengths on 08 February 1977. As Public Assessment Reports (PARs) are currently only available for new marketing authorisations (MA’s) granted after 30 October 2005, the licences mentioned above have not been issued PARs. Would it therefore be possible for the MHRA to provide the non-clinical/clinical expert reports for these MAs? 19/11/2020 Disclosed in part
FOI 20/438 28/10/2020 I am writing to the MHRA to ask for details of adverse drug reports from 1998 to 2020 to Minoclycline, Nitrofuantoin; and Ciprofloxacim 25/11/2020 Disclosed in full
FOI 20/439 07/11/2020 I am requesting to be informed of the number of reports received by the MHRA of adverse sexual effects caused by SSRIs. 03/12/2020 Disclosed in full
FOI 20/440 09/11/2020 Please provide a list of all the clinical trials used to establish the UK practice recommended for 5-FU based chemotherapy regimens based on Body Surface Dosing (BSA) and a copy of all literature reporting the design, implementation and/or outcome of those trials. 01/12/2020 Not released
FOI 20/441 10/11/2020 I would like Freedom of information in regards to funding of MRHA. I would like to know if you have recieved funding from the Bill and Melinda gates foundation and whether you are government funded.  19/11/2020 Disclosed in full
FOI 20/442 12/11/2020 Please provide the following information: The contract awarded to Genpact (UK) Ltd for procurement of an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) to ensure that no details from the ADRs’ reaction text are missed. The information determining the anticipation of a “[high volume] of COVID-19 vaccine Adverse Drug Reaction’s (ADR’s) and details of the anticipated ADR’s. A list of active and inactive ingredients so far known to be contained within the overtly bleated Pfizer and other manufacturer COVID-19 vaccine. 10/12/2020 Disclosed in part
FOI 20/443 09/12/2020 I would specifically like to receive details on a drug called SNG001 which is manufactured by Synairgen based in Southampton, England. The drug completed a Phase 2 study in July 2020, with best in world results. The Health Minister is aware of this Covid19 treatment, as it was part of his televised emergency briefing in July, as a result there must be Government documents relating to this drug. Please note this drug is not part of the favoured Oxford Recovery trials.  08/12/2020 Not released
FOI 20/444 12/11/2020 I’m researching what MHRA is doing to ensure that Covid 19 vaccines are properly regulated and safe for the public to use.  My attention has been drawn to an MHRA contract award notice for an 'Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) and ensure that no details from the ADRs’ reaction text are missed’. I couldn’t find anything about this contract on your website so I hope you can help me by answering a couple of questions. Why do you expect the volume of ADRs to be high? Is the software intended for Covid 19 vaccines that are still at the trial stage, or is it for any Covid 19 vaccines that MHRA will approve in the future?  16/11/2020 Disclosed in full
FOI 20/445 12/11/2020 I therefore request: 1. A list of all records relating to previous coronavirus pre 2018. 2. I notice MHRA has not transferred records to the National Archives. Can I have an explanation of: A) in the view of the Departmental Records Officer, how many of their historic holdings ( again pre 2018) if transferred to TNA would have been helpful in combatting coronavirus. B) why MHRA has not transferred historic records. Again the DRO response rather than a generic from comms please. C) whether coronavirus will change the transparency of MHRA and make it more willing to share it's records with researchers 08/12/2020 Disclosed in part
FOI 20/446 09/11/2020 I would also like to see the new data which will appear for the covid 19 vaccine once this is being administered to the first set of people eligible to have it.  I’d like to continue receiving the data for covid 19 vaccine at a later stage next year when more people have been given it.  08/12/2020 Disclosed in full
FOI 20/447 12/11/2020 we request the Clinical and Non-Clinical Overviews submitted for PL 20941/0003 Paracetamol 120mg/5ml Oral Suspension that was granted under Article 10a (WEU) in March 2009 under the Freedom of Information Act. 10/12/2020 Not released
FOI 20/448 13/11/2020 Information on a list of the current ongoing/approved/withdrawn/cancelled Marketing Authorisations of medicinal products which contain the sucralfate active substance. Please include details like Product name with strength/formulation, MAH name, Legal basis of application at the time of approval, UK national or MR/DC procedure, API CEP/DMP holder details,  License status, date of approval/cancellation/withdrawn for each marketing authorisation. If available, please arrange public assessment report (PAR) for each Marketing authorisation or advise which EU authority to contact if they are part of DCP/MR procedure.  19/11/2020 Not released
FOI 20/449 13/11/2020 Please could you inform me as to whether or not the Covid Vaccine will be Vegan? Please could you Inform me if you have made any Appraisal of the Male Health Company -Foregen? 17/11/2020 Not released
FOI 20/450 14/11/2020 There is a news clip on social media saying that MHAR are looking to purchase chase an AI tool to monitor the "expected level" of adverse reactions to the Covid Vaccine. Clearly if true this is worrying for the public  Could you firstly advise if the report it true and secondly if true can I have the details of what are the "expected levels" of adverse effects and what are the effects and who are likely to be effected  17/11/2020 Disclosed in full
FOI 20/451 14/11/2020 Concerns over the potential ADRs related to the new COVID19 vaccine in development. In the interest of public health, can you provide details of what these ADRs may be? How does MHRA intend to prevent further reactions with the use of AI, and why is this preferable to a higher degree of testing of the vaccine before it is released? 17/11/2020 Disclosed in full
FOI 20/452 16/11/2020 Under the freedom of information act I am requesting information regarding the above mentioned bone substitute:- 1. Please can you tell me why BoneSave by Stryker which was used in my spinal fusion in 2010 at MPH has now been withdrawn/discontinued? 2. Can you tell me whether any other patients were ill/had problems relating to the use of this in conjunction with Synthes titanium hardware or any other hardware? 3. How many other patients had to have their hardware removed after receiving this bone substitute? 25/11/2020 Disclosed in full
FOI 20/453 16/11/2020 Can you list all the ingredients for the new covid-19/ AZD1222 SARS-COV-2 vaccine? In the next 5 to 10 years, can I have a list of all the possible side effects this may have? 17/11/2020 Not held
FOI 20/454 17/11/2020 Please disclose all known vaccines on the U.K. vaccine schedule which contain aborted human foetal cell line products. Please disclose all known adverse reactionary outcomes or side effects caused by the use of aborted human foetal cell line products in vaccine subjects. 16/12/2020 Disclosed in full
FOI 20/455 17/11/2020 i would like the adverse drug reaction data for both the Repevax and MMR. Im not sure the rage of data you cover? or what is avaliable, could i also have any data you have on ingeditents mainly- WI-38, Hydrolysed gelatin, the aluminium prosphate, bovine serum. Any information you have on Guillain-Barre syndrome. I would also like to see the data of trials where both the repevax and the MMR being iussed at the same time? also do you hold any information how the 3-month-gestation aborted female fetus (WI-38) is obtained? 15/12/2020 Disclosed in full
FOI 20/456 17/11/2020 would you happen to be able to confirm the main ingredients of the main candidates for COVID-19 vaccination products? I’ve read somewhere that at least one such product under testing from one of the larger pharma companies has been formulated from recombinant DNA harvested from 14-day-old aborted human foetuses – I wonder if that part is true. . . . 17/11/2020 Not held
FOI 20/457 02/11/2020 we are looking for is the assessment report on Neupogen pediatric indication extension (Neupogen 30 MU (0.3 mg/ml) solution for injection - Paediatric extension of indication, implemented 31.01.1997,  with the UK as RMS). 16/11/2020 Other
FOI 20/458 17/11/2020 FOI request for PL 18259/0010, PL 18259/0011 & PL 18259/0012 Chloralieve Lozenges. The Public assessment Report (PAR) published for these products. The naming justification used to obtain ‘Chloralieve’. 19/11/2020 Not held
FOI 20/459 17/11/2020 I would be grateful if M H R A, as a competent authority and regulator, could consider the important information provided by Dr Kaufman and respond to the following enquiry regarding "mRNA vaccines" at your convenience. Have mRNA vaccines previously been approved by regulators for use in the human population. Are the genetic modifications, referred to by Dr Kaufman, transferred from parent to offspring, with unknown impact on the next generation. Has the "electroporation" process for administering vaccines previously been approved for use in the human population by regulators. Is M H R A aware of any peer-reviewed medical / scientific paper on the subject of mRNA vaccines for use in the human population. 16/12/2020 Disclosed in full
FOI 20/460 18/11/2020 Could you please provide up to date Names, Job Titles, telephone numbers and email addresses for the following; Chief Executive, Deputy Chief Executive, Ministers Chair, Chief Information Officer, Chief Director of IT/Head of Finance, Chief / Deputy Chief Operating Officer, Board members (if applicable) 27/11/2020 Disclosed in full
FOI 20/461 16/11/2020 I would like to place this freedom of informaton request. Please do feel free to contact me if any of the below is uncear of if you have any questions. How would Artificial Intelligence software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction differ from the traditional yellow card system? Does the MHRA accept that the yellow card system has failed in determining the true extent of vaccines damage? If vaccine based viral vectors are used in molecular biology to switch on mutated genes, does the MHRA accept that vaccines safety had been overlooked? 10/12/2020 Disclosed in full
FOI 20/462 18/11/2020 Request Risk Management System for Sitagliptin/Metformin 04/12/2020 Disclosed in full
FOI 20/463 18/11/2020 I would like a print-out/line listing of individual cases/reports submitted of people suffering adverse side effects of the combined contraceptive pill Rigevidon, detailing information from 2018 to 2020. I would like the information annually starting from January until December (or until November in the case of 2020).  17/12/2020 Disclosed in full
FOI 20/465 18/11/2020 I should be most grateful if we could obtain the following documents for the medicinal product " Glycopyrronium Bromide 1 mg/5 mL oral solution", PL 41344/0010, MAH: Colonis Pharma Limited. Clinical Overview, Preclinical Overview, Risk Management Plan, Public Assessment Report 17/12/2020 Disclosed in part
FOI 20/466 19/11/2020 Please may I have a breakdown of the number of civil servants employed at the MHRA stratified by their Civil Service grade band (i.e. HEO, SEO, Grade 6, etc.). Could you provide MHRAs job grade and the salary bands, showing national, outer london, and inner london pay bands 09/12/2020 Disclosed in full
FOI 20/468 20/11/2020 Under FOI Act, we request the MHRA to provide UK PAR for below mentioned licensed product: Ceyesto 3 mg tablets, MA Number PL 16784/0004, HK Pharma Ltd 24/11/2020 Not held
FOI 20/469 20/11/2020 Further to the FOI that was completed in July 2020, would it please be possible to receive an update on the Diazoxide preparations and Povidone-Iodine Preparations breaking the data down to the pharmaceutical dosage form, and if possible the strength, that is being imported. 14/12/2020 Disclosed in full
FOI 20/471 21/11/2020 I am requesting information on how the MHRA is funded. This should include:Names of all organisations who fund the MHRA. What purpose each individual payment is intended for. The percentage of the MHRA funding from each organisation. The total amount of funding from each organisation (GBP) 25/11/2020 Disclosed in full
FOI 20/472 22/11/2020    I am extremely alarmed to hear that the MHRA has accepted substantial amount of funds from  Bill Gates.  Is this true and if so how much. If so I  have no doubt that this vaccine will be passed as completely safe whether it is or not and at the moment Who knows about the mid to long term problems to surface?  Do you know?  No? But if the MHRA does pass this vaccine as safe   I will have as much faith in your reasons and arguments as I do in the pronouncements of Sage who also collect indirectly substantial funds from the same source  30/11/2020 Disclosed in full
FOI 20/473 20/11/2020 PL 04425/0883 Ibuprofen and caffeine sanofi 400 MG/100 MG film-coated tablets. We would like to make a request under the Freedom of Information Act, for information held on the product listed above. Specifically, we would like you to provide us with:The Public assessment Report (PAR), The Risk Management Plan (RMP), Clinical Overview 25/11/2020 Not held
FOI 20/474 22/11/2020 I  also make a freedom of information request that you supply me with the following information:1 Please confirm the total numbers of deaths in the UK FROM Covid19 between 1st march 2020 and 1st November 2020. 2 Please confirm the number of deaths FROM covid19 for each individual month, from march through to November 2020. 3 Please supply evidence that SARSCOV2 has been proven to exist. 4 Please supply evidence that SARSCOV2 is the cause of the illness COVID19. 5 In order to approve any vaccine or product for emergency use, you must hold evidence and be able to prove that an emergency exists. 30/11/2020 Not held
FOI 20/475 23/11/2020 are the board members who have shares in vaccine companies, and or get funding from drug companies being excluded from all decisions about vaccines in the UK and especially with the new covid-19 vaccines and medicines? 2. when making these decisions do you take into account there are other options to help with corvid-19 like HCQ/Zinc combination in the proven studies around the world and the withdrawn study against from the lancet and also other medicines and therapies? 23/12/2020 Disclosed in full
FOI 20/476 23/11/2020 I am working on evidence review of anti-cataplectic drugs and I was looking for PAR (or EPAR) on clomipramine for its UK license for cataplexy associated with narcolepsy (trial data, study design, questionaires or measurment used to assess efficacy). I did not find this level of data on the MHRA website, or on the European Medicines Agency website and the FDA did not grant clomipramine license for cataplexy. 26/11/2020 Not held
FOI 20/478 24/11/2020 Lenalidomide - request any UK specific documentation relating to the RMP for these products, such as the educational materials and communications to healthcare professionals, patient information, and prescription authorisation form, to the extent they have been submitted by the relevant manufacturer? 30/11/2020 Not held
FOI 20/479 23/11/2020 How can Dr June Rainer professes that she will only authorise the vaccines if they pass safety tests. The above answers her question. They are not safe. The test protocols for the vaccines are such that they do not have to show that they stop transmission, stop hospitalisation or deaths. What therefore is the point? mRNA vaccines have never been used on humans before, the trials are far to short to show the side effects. 2014 mRNA vaccine trial showed that all ferrets died. 22/12/2020 Disclosed in full
FOI 20/481 27/11/2020 Please disclose a clinical review or study paper into Randomised Control Trial’s demonstrating the safety of Aluminium Adjuvants contained within any Vaccine. 1.1 If the previous disclosure requirement (1) is prohibitive, please disclose any other form of documentary evidence demonstrating that Aluminium Adjuvants contained within Vaccines are safe. 2. Please disclose a list of all known nano-particles currently contained within any Vaccine on the U.K. Vaccine schedule. 3. Please disclose any clinical evidence that nano-particles of any substance contained within Vaccines are incapable of crossing the blood-brain barrier. 24/12/2020 Disclosed in full
FOI 20/483 27/11/2020 Please can I request, from the Medicines and Healthcare products Regulatory Agency, copies of all email correspondence containing the phrase 'target product profile' and also the phrase 'SARS-Cov-2' and fitting all three of the following criteria: 1) Message sent or received since 01/03/2020; 2) Message sent to or from an MHRA employee or board member; 3) Message sent to/from another MHRA employee or to/from a Department of Health and Social Care employee (suffix @dhsc.gov.uk) or to/from a government minister. 11/12/2020 Not released
FOI 20/484 27/11/2020 I wish to submit a request to the organisation around their hosting contract(s) with 3rd party providers. The type of contract I wish to see is below: Cloud Hosting- Cloud hosting services provide hosting for websites on virtual servers, which pull their computing resource from extensive underlying networks of physical web servers. 23/12/2020 Disclosed in full
FOI 20/485 28/11/2020 In accordance with the Freedom of Information Act, I am requesting a copy of the minutes for the of the Clinical Trials, Biologicals & Vaccines Expert Advisory Group, for all meetings in 2020 up to the current date, 28th November 2020. 29/12/2020 Disclosed in full
FOI 20/486 28/11/2020 Under FOI Act 2000, please provide me with the following: 1) Nasal Flu Vaccine Efficacy rates for the past 5 years. 2) Data on yellow card reporting for the nasal flu vaccine for the past 5 years 24/12/2020 Disclosed in full
FOI 20/487 27/11/2020 Is it true what I'm hearing about vested interests and conflicts of interest regarding your forthcoming assessment of the upcoming vivid vaccine? I'm referring to things such as previous employment within vaccine development companies and in particular investment in coronavirus vaccines on the part of MHRA employees? 18/12/2020 Disclosed in full
FOI 20/488 27/11/2020 From the time the first notification of Coronavirus vaccine human trials within the UK was registered by MHRA, until you anticipate approval for vaccination of the UK general public (presumably mid 2021): Are MHRA provisioning additional resources to expedite vaccine approval for SARSs, as follows: a) How much extra funding has been / will be specifically provided from public sources and … b) … from other sources? (Recognising details of private funding may be confidential) c) By how many people has MHRA’s expert/technical team staffing level been increased (or is planned to increase) to cope with the extra regulatory work due to the vaccines? d) If the European Medicines Agency approves a vaccine for the EU prior to 1 Jan 2021, will the MHRA automatically approve that vaccine for use in the UK and extend approval beyond the end of the Brexit transition period (i.e. into 2021)? e) What provisions are being made for enhanced patient liaison and monitoring of delivery, effectiveness and side effects during the initial vaccinations? Recognising that these vaccines’ development has been greatly accelerated because of the health emergency. 22/12/2020 Disclosed in full
FOI 20/489 30/11/2020 1. A complete list of ALL Peer Reviewed Clinical Evidence for Tests and Protocols for the RT PCR tests currently being used to determine the infection rate of SARS – CoV-2 with or without symptoms, in the British public, which conclusively demonstrate the reliability, specificity and robust ability of the Testing regime and the results obtained. 2. A complete list of all Peer Reviewed Clinical Evidence showing the isolated genomic RNA of the virus – referred to as SARS- CoV-2. 22/12/2020 Not held
FOI 20/490 01/12/2020 Pharmacovigilance & GCP inspection reports be provided for all Companies that had major or critical findings please from April 1st 2020 – 31st August 2020. 21/12/2020 Disclosed in part
FOI 20/491 01/12/2020 Can you please supply the full list of ingredients used in the development, production and manufacture of the new vaccines for Sars-Cov2, Covid-19, coronavirus. 08/12/2020 Disclosed in part
FOI 20/492 27/11/2020 Dakarin 2% Oral Gel Dosage 23/12/2020 Disclosed in full
FOI 20/495 01/12/2020 Freedom of Information Act to request regulatory information on Lamisil 1% Spray. The information that I am requesting is as follows: The date of first authorisation of Lamisil 1% Spray, The authorisation holder, Regulatory basis of the authorisation, Legal classification of the product at the time of grant of the authorisation, Copies of Public Assessment reports 28/12/2020 Disclosed in full
FOI 20/497 02/12/2020 Please provide copies of the following three GMP Inspection reports: Almac Clinical Sciences (MIA-IMP 20377), 27 July 2020, Almac Clinical Sciences (MIA-IMP 20377), 21 March 2019, Catalent UK Packaging (MIA-IMP 1380), 19 Sept 2017 30/12/2020 Disclosed in full
FOI 20/498 02/12/2020 CanG497:G498 you provide me with the trials for the elderly and the vulnerable for the Pfizer covid vaccine please? Safety and efficacy studies for this group as they are being selected as the first round of guinea pigs. Its my understanding this group of people are not included in 23/12/2020 Disclosed in full
FOI 20/499 02/12/2020 1. How many had existing comorbidities eg epilepsy, copd, obesity, heart failure, kidney issues, psychosis, asthma. 2. How many were/are on meds such as inhalers, heart meds, lamotrigine, tramadol, adcal, alendronic acid, spironolactone, pizotifen, quetiapine, paracetamol, montelukast, sleeping pills etc. 3. Did the vaccine react or stop other meds from working? 4. Did anyone have any allergic reactions? Like swelling of lips & throat? 23/12/2020 Disclosed in full
FOI 20/500 02/12/2020 I am looking for the breakdown of the participants in the Pfitzer COVID-19 vaccination trial (approved 02 12 2020) by sex, under the Freedom of Information Act of 2000. Please include any information on side effects noted between the two 23/12/2020 Disclosed in full
FOI 20/502 02/12/2020 Can you please provide me with the results of the safety and efficacy trials for the elderly and vulnerable in the Pfizer vaccine. I believe that these groups are among the first to be “offered” said vaccine.  21/12/2020 Disclosed in part
FOI 20/503 11/12/2020 Would you be able to share with us summary of reference product RMP? Reference product for this procedure is Strattera from Eli Lilly (MA number in UK for 10 mg PL 00006/0375). 22/12/2020 Disclosed in part
FOI 20/505 02/12/2020 •The overall expected ADR’s •In in turn these figures by age. That you will ensure the public will be widely informed at all times. •The list of expected ADR’s in all groups, and then by age. •How many prolonged hospitalisations are expected, and then by age. •How many long term complications, and then by age. •The estimated number of fatalities, and by then by age. •The source(s) of the information you are relying on to make these estimates 04/01/2020 Disclosed in full
FOI 20/506 02/12/2020 1. Information on studies and tests declaring Covid19 vaccine to be safe 2. correspondence of public interest between the parliament and MHRA in regards to rapidly processing safety reports for the Covid19 vaccine. 3. The reason why this vaccine requires such a temperature equivalent to that of Cryostasis?. 4. Evidence to suggest that the Vaccine is necessary for use on the general population considering that Covid19 was declared a NON HCID back in March on the 19th 2020 by Public health England. 5. list of all funding bodies, financial assistance and share holders currently registered with MHRA. 6. The last 3 month’s of spending by the MHRA and what if possible they were used for by whom and what purpose. 7. Risk assessment data on the Covid 19 vaccine. 8. any other documents deemed public interest over the last 2 months 9. what specific mRNA data held by MHRA regarding Covid 19 vaccine, and included side effects of such mRNA regarding Covid19 vaccine. 10. Covid19 vaccine leaflet/documentation list of ingredients etc and anything else important to the people of the UK in respects to public interest and safety concerns. 21/12/2020 Disclosed in part
FOI 20/507 03/12/2020 > 1) Please name the studies that indisputably show that the SARS-Cov-2 virus has been proven to exist (complete purification, isolation and definition of biochemical properties plus electron micrographs) > 2) Please name and identity studies that indisputably show that SARS-Cov-2 causes disease (and that other factors like malnutrition, co-morbidities, toxins etc. do not, at least, co-determine the course of the disease) > 3) Please name at least two peer reviewed studies that show vaccinations to be both effective and active. 16/12/2020 Disclosed in full
FOI 20/508 03/12/2020 THE FULL APPLICATION MADE BY PFIZER OR ANY CONNECTED COMPANY OR ORGANISATION OF PFIZER WITH REGARD TO THE COVID 19 VACCINE MANUFACTURED BY THEM AND PURCHASED BY THE BRITISH GOVERNMENT. ALL AND ANY FULL COPIES OF THE SUBMITTED DATA AS TO TRIALS, SUBJECTS AND OUTCOMES OF THE TRIALS FOR THE VACCINE, IN REPORTS, GRAPHS ET AL. CLAIMS AS TO SAFETY AND EFFICACY OF THIS VACCINE AND FULL AND FRANK APPLICATION MADE BY THE SAID COMPANY TO YOURSELVES COVERING ALL ASPECTS OF THE APPLICATION AND USES OF THIS VACCINE ON THE PUBLIC. A FULL AND PRECISE REPORT OF EVERY INCLUSION, INGREDIENT ADDITIVE FOUND IN THIS VACCINE. A FULL AND FRANK REPORT BY YOURSELVES OTHERWISE KNOWN AS MHRA OF ALL THOSE CONSIDERING SAID APPLICATION AND TAKING PART IN THE DECISION MAKING THE NAMES AND POSITIONS OF ALL THOSE WHO CONSIDERED THE APPLICATION ITS FINDINGS AND OUTCOMES, ALL AND ANY INFORMATION REGARDING THE APPLYING COMPANY, YOURSELVES. DATA AND INFORMATION PERTAINING TO THE SAID APPLICATION. 31/12/2020 Disclosed in full
FOI 20/509 03/12/2020 Whereas the Govt. has planned to coerce the public into accepting the novelty of an mRNA covid-19 vaccine without a recourse: The Declaration of Helsinki and the Nuremberg convention oblige you to provide the evidence of that your verification of the data from Pfizer, Moderna, AstraZeneca, Novalis; do confirm that their covid-19 vaccine: 1) is causing an anamnestic response; 2) is a prophylactic treatment against Covid-19; 3) will protect against a SARS-CoV-2 infection; 4) will prevent serious Covid-19 and/or influenza complications; 5) will reduce, for those over the age 60 their covid19 CFR to less than 0.1% (Influenza A); 6) will reduce, for those under the age 60. their covid19 CFR to less than 0.01% (ses-flu); 7) does fulfil the criteria for to be a genuine vaccine; 8) its safety profile (its health benefits -vs- ADRs risks) has been calculated according to the standards for general medications and does fulfil clinical and regulatory milestones; 9) its safety profile rate is such that with a scientific calculated probability said vaccine can be safely enforced as a mass inoculation and does justify its Harmless clausula. 16/12/2020 Disclosed in full
FOI 20/510 03/12/2020 REQUESTED RECORDS 1. Clinical overviews, non-clinical overviews and risk management plans for the Pfizer/BioNTech Covid-19 vaccine; 2. List of meetings held between MHRA and Pfizer/BioNTech held within the past 12 months; and 3. Data/clinical trial results relating to the Pfizer/BioNTech Covid-19 vaccine and correspondence relating to the decision to grant it a license. 24/12/2020 Disclosed in full
FOI 20/511 02/12/2020 Galderma Calmurid Cream ingredients "possibly carcinogenic to humans " 30/12/2020 Disclosed in full
FOI 20/512 03/12/2020 (FOIA)-Report of Good Manufeturing Practice (GMP) inspection report for Surepharm Service Ltd 30/12/2020 Other
FOI 20/513 02/12/2020 My i see the report containing the data you have based your approval on please? I need to personally assure myself that it is safe before i make a decision to have the vaccine. 22-12-20202 Disclosed in full
FOI 20/514 02/12/2020 1. Has the MHRA received funds from the Gates Foundation and the extent of the funds and what it was used for. 2. All information regarding the Pfizer/ biotech vaccine 3. All known studies of the Pfizer/ biotech vaccine that MHRA 30/12/2020 Disclosed in full
FOI 20/515 04/12/2020 May I therefore submit a Freedom of Information request now, (in case the aforementioned public document does not contain the relevant information), for documentation of the full Pfizer trial review by the MHRA and subsequent recommendation? 21/12/2020 Not released
FOI 20/516 02/12/2020 What does the vaccination approval certificate allow..? For emergency or annual repeat use? Without a longitudinal study, how can they ensure the safety of the vaccine in the 'long term'? For 'how long' will the immunity post vaccination last? Will an annual vaccination, like flu, be required? 22/12/2020 Disclosed in full
FOI 20/517 05/12/2020 I am curious as to the status of Monoclonal antibody medicines for the treatment of cluster headache (Horton's disease).  I am aware that the EMA has not licenced Emgality for treatment of CH but do not know if the MRHA has assessed the efficacy and potential for any of the Monoclonal antibodies (Emgality, Ajovy and Almovig). 16/12/2020 Disclosed in full
FOI 20/518 07/12/2020 Names of all suppliers since March this year whose PPE the MHRA has deemed unfit for the purpose intended Copies of all reports relating to PPE products the MHRA has deemed unfit for the purpose intended. 22/12/2020 Other
FOI 20/519 02/12/2020 I'm unable to find any detailed publication of results for the recent covid vaccine trials which MHRA has just approved for use with the public. I should be most grateful if you could pass on this information to me 22/12/2020 Disclosed in full
FOI 20/520 04/12/2020 1. Please disclose any recorded information proving that a SARS-CoV-2 virus exists in Nature. 2. Please disclose any recorded information proving that a COVID-19 disease exists in Nature and is proven to be caused by a SARS-CoV-2 virus. 3. Please disclose any recorded information that the Pfizer vaccine said to mitigate symptoms of a COVID-19 disease is proven safe and effective against a SARS-CoV-2 virus, or in simple terms, is proven to provide immunity against a purported SARS-CoV-2 viral infection. 4. Please disclose any recorded information demonstrating the evidence that a SARS-CoV-2 virus is capable of transmission causing COVID-19. Note: this requires evidence that an identifiable SARS-CoV-2 virus [nucleic acid particle] travelling through the air from a subject in aerosol or some other form and is caught or received by another subject who then goes on to suffer with COVID-19, the purported disease resultant or caused by a SARS-CoV-2 virus. 5. Please disclose any recorded information demonstrating the evidence that a SARS-CoV-2 virus is capable of spread, by being exhaled in sputum or other bodily fluid from a subject onto and retained on a surface [and the time period established for SARS-CoV-2 to remain as a living organism] so as to be collected or picked up by a second subject at any point within the recognised and proven timeframe. 6. Please disclose any recorded information proving that face coverings mitigate the transmission and spread of a SARS-CoV-2 virus. 7. Please disclose the proof that a RT-PCR, Rapid antigen test or any other test is capable of identifying a SARS-CoV-2 virus. 22/12/2020 Disclosed in full
FOI 20/521 02/12/2020 Request for data - COVID 04/01/2021 Disclosed in full
FOI 20/522 07/12/2020 1. A list of the Pfizer/BioNTech Covid-19 vaccine ingredients. 2. A copy of the peer-reviewed (if applicable) or other study and trials data. 3. A demographic and health profile of test subjects (if not included in the study data). 4. The name of the journal or publication in which the study/trials data is published. 5. A copy of any emails, notes, and minutes from meetings about the vaccine, and/or its safety, and/or concerns about risks. 30/12/2020 Disclosed in full
FOI 20/523 04/12/2020 What synthetic 3'-deoxyribose nucleic acid (RNA) sequence or sequences (e.g. N Gene; Genbank accession: MN908947.2) are supplied as reference standards for the real time reverse transcriptase chain reaction (rRT-PCR) test or tests used for detecting the putative virus SARS-Cov-2 that are either in production or being validated by the National Institute of Biological Standards and Controls (NIBSC)? Specifically this request relates to the sequences of: 1. The Research reagent for SARS-CoV-2 RNA NIBSC code: 20/110 2. The 1st WHO International Standard for SARS-CoV-2 RNA 24/12/2020 Not held
FOI 20/524 07/12/2020 1. What instructions were trial volunteers given with respect to challenging themselves to contract the virus. Were precautions like social distancing or mask wearing advised during the trial. Did this differ in different locations? If so how did this impact results. 2. Was the split between vaccine and placebo evenly distributed across sex, age groups and trial locations. 3. What was the prevalence of the virus in each trial location during the trial. 4. What was the distribution of positive cases across trial locations, ages, sex, . 5. How and by whom were positive covid cases determined? What symptoms were recorded for the confirmed covid cases. 6. A number of side effects of the vaccine were identical to indicative symptoms of covid e.g. fatigue, headache, chills. How were these differentiated? 7. What steps were taken to eliminate the risk of PCR test false positive results. 8. Did any of the positive cases require medical treatment if so what. Were there any severe cases that required any hospitalisation or ICU. What was split between vaccinated and placebo. 9. Were any cases identified before the time when a valid positive trial case could be recorded (7 days after second dose) 10. What were the exact numbers of adverse reactions recorded split by sex, age and ethnicity. Of these how many required medical intervention and if so what did this consist of. Were any admitted to hospital. ICU? 11. S6.6 of Pfizer trial protocol allows for dose modification. How often did this occur and was it for any of the positive cases 12. S6.6 of the trial protocol outlines the possibility that due to medication error a participant may have been given vaccine in first dose and by mistake the placebo in second dose. These trialists would then be offered a second dose of the vaccine at another time. Did this happen? Did it impact any positive cases? 13. S7.1 of the trial protocol outlines situations where participants discontinued the trial or declined the second dose. How many times did this happen? 16/12/2020 Disclosed in full
FOI 20/525 07/12/2020 Can you provide to me the clinical datas (preliminary clinical study report and PSUR / DSUR if it exists) submitted by Pfizer for it's COVID-19 mRNA vaccine BNT162b2 ? 18/12/2020 Disclosed in full
FOI 20/526 07/12/2020 Please supply all the phase III clinical trial data submitted for approving the Pfizer-Biontech cov-19 vaccine. 16/12/2020 Disclosed in full
FOI 20/527 02/12/2020 concern about Covid-19 Oxford-AstraZeneca vaccine trials (CSC 22904) 31/12/2020 Disclosed in full
FOI 20/528 03/12/2020 Pardon my ignorance but I have been unable to find the full data in a peer reviewed journal. If I am incorrect please could you advise me of where this is published? If not, would you be kind enough to forward the data in full for me to review? 18/12/2020 Disclosed in full
FOI 20/529 03/12/2020 COVID-19 vaccine: BTN162b2 RMP pharmacovigilance plan 31/12/2020 Disclosed in full
FOI 20/530 02/12/2020 Please could you tell me Has this vaccine been through testing on people with underlying health issues or has the trails been Purely on healthy people? 07/01/2021 Disclosed in part
FOI 20/531 03/12/2020 > * I would like a copy of the results data on the trials that were carried out. > * I would like to see the peer reviewed study. 21/12/2020 Disclosed in full
FOI 20/532 07/12/2020 1) I would like to know what the indemnity/ liability clauses are with the vaccine that is to be rolled out this month. Furthermore I would also like to know who is liable for any adverse side effects that occur. 2) I would also like to know why Pfizer and the NHS staff administering the doses required full indemnity? 3) What trials/ stages of vaccine development have either not been completed in full (as they would with other vaccines), or have had a much less stringent testing process? 4) Can I have a full list of vaccine ingredients, including their uses and side effects. (I would also like to know how each chemical interacts with eachother as they could be harmless on their own but react badly when they interact with eachother). 06/01/2021 Disclosed in part
FOI 20/533 07/12/2020 1. Planned date for the completion of animal reproductive toxicity studies 2. M H R A ' s current assessment of risk to newborns / infants 3. An explanation why temporary authorisation has been granted by M H R A for roll-out of vaccine to the human population if the impact on fertility is unknown and the outcome of animal reproductive toxicity studies is awaited. 06/01/2020 Disclosed in full
FOI 20/534 05/12/2020 You have received substantial amounts of money from the Bill and Melinda gates Foundation. Please provide all emails regarding this from and to the organisation. 04/01/2021 Disclosed in part
FOI 20/535 06/12/2020 Is it correct that the MHRA received £980,000 (or, possibly, $980,000) from the Bill and Melinda Gates Foundation? In case that is too precise, has the MHRA received any money whatsoever from the Bill and Melinda Gates Foundation (or their affiliates) in the last five years? 24/12/2020 Disclosed in full
FOI 20/536 07/12/2020 Under the FOI Act, please tell me if it is true that the MHRA has accepted a Gates foundation donation of circa £980k for ‘cooperation’. And, if so, why was that and what have you used it for? 24/12/2020 Disclosed in full
FOI 20/537 20/11/2020 Why is melatonin not available over the counter in pharmacies? Why prescription only? 16/12/2020 Disclosed in full
FOI 20/538 08/12/2020 Under FOI How many patients were prescribed the drug Elmiron in the UK between 01.01.2018 and 01.12.2020? How many cases of Elmiron related eyesight defects were recorded in the same period? 07/01/2021 Disclosed in full
FOI 20/539 07/12/2020 Please provide relevant documentation including, but not limited to, SPCs, patient information leaflets, medical practicioner guidance, and authorization documents in relation to any and all vaccine products approved by MHRA and other government agencies for the prophylaxis / prevention / elimination / inoculation of the Covid-19 virus. 15/12/2020 Disclosed in full
FOI 20/540 08/12/2020 1. How long does the vaccine confer immunity to sars-cov-2 infection? Provide published evidence. 2. Does the vaccine prevent transmission of Sars-cov-2 virus. Provide published evidence. 3. What are the most likely adverse reactions and long term unintended effects of the vaccine? Provide published evidence. 4. Does the vaccine improve health economic outcomes? For example reduce hospital admissions. If so, please provide published evidence. 22/12/2020 Disclosed in full
FOI 20/541 02/12/2020 Please could you send me the Risk Management Plan for the Pfizer Covid-19 vaccination with appendices. I would like to assess the risk myself before considering vaccination. 31/12/2020 Disclosed in full
FOI 20/542 07/12/2020 We would like to make a Freedom of Information request for any guidance, policies, correspondence or other materials relating to action (intended, planned, cancelled or otherwise) against any companies breaching regulations relating to anti-viral claims for hand sanitisers from 1 January 2020 to the present day. We wish to establish the extent to which MHRA has considered or undertaken any action against any organisation making claims about hand sanitiser products in relation to protection against SARS-CoV-2 (which causes COVID-19). 06/01/2021 Disclosed in full
FOI 20/543 09/12/2020 request the GCP Inspection Reports with RSI scope in years 2018, 2019 and 2020. If narrowing the scope to RSI is not possible please provide us with a list of GCP inspections in same time frame and we will select reports more relevant to us for benchmarking and training purposes. 30/12/2020 Not released
FOI 20/544 07/12/2020 I’m looking for some information on a preclinical trial that started on Oct 26, 2020 for a unspecified route for the Pulmatrix Pipeline in lung cancer. I’m assuming this is for Pur1800 oka RV1162 and the sponsor is JNJ or Janseen .  Could you verify this is accurate please? 18/12/2020 Not held
FOI 20/545 09/12/2020 Please provide all correspondence and reports this year between the MHRA and the Department of Health in relation to the supply of the surgical gowns by PPE Medpro. Please also provide any declarations of conformity or certificates of conformity supplied by PPE Medpro in support of these products. 22/12/2020 Not released
FOI 20/546 08/12/2020 1. Please tell me costs for covid vaccine authorization in U.k. costs - this includes emergency authorization and registration? 2. Please tell me the Mhra rules for foreign embassies and high commissions in London when it comes to them importing specifically from their home countries their government's recommended and licensed covid vaccines into the U.k. for use on their embassy and high commission staff and also for their citizens and non-residents who are residing in the U.k.? Is it allowed? Do these diplomatic venues - embassies and high commissions, require Mhra to authorize the vaccines before they are used only in these venues (embassies and high commissions) - in other words they are not going to be injecting the covid vaccines outside their venues (embassies and high commissions) nor injecting the ordinary population? 07/02/2020 Disclosed in full
FOI 20/547 08/12/2020 I am contacting you to ask when that will be published as I am diagnosed as having ME/CFS/FIBROMYALGIA and would like to know if any fellow sufferers were involved in the phase 3 trials, and if so was there any exacerbation of their symptoms following its administration? 29/12/2020 Disclosed in full
FOI 20/548 - No longer FOI Not set Not set Not set Not set
FOI 20/549 18/11/2020 Coproxamol - Thanks again for your prompt response, I would like all the redacted details displayed on your chart included as this would enable me to see which company is overcharging the NHS. Re: The latest available data from open prescribing reveals: - Co-proxamol Top saving opportunities for NHS England in August 2020 16/12/2020 Disclosed in full
FOI 20/550 02/12/2020 Core RMP for Covid-19 vaccines 31/12/2020 Disclosed in full
FOI 20/551 08/12/2020 What was the health status and demographics of the study population? Was this group representative of the population this vaccine is intended for? What were the results? Are they significant? What are the limitations of the study and how does this subtract from the relevance of the outcome? Please will you answer those questions individually if this information is not available in the directly above question requesting information release? Has there been independent reviews of this work prior to vaccine approval for use? Was the PCR test used to determine a Covid-19 infection? Is there a list of any safety concerns or contra indications for those who take this vaccine? What, if any, are its interactions with other medicinal products? If side effects cannot yet be established prior to use, how will informed consent of the vaccine recipient be established by the administrator of the injection? If no longitudinal studies are available and this is experimental as a treatment, why is it not classified as a clinical trial as opposed to being called a vaccine? Who will hold accountability and who has compensatory responsibility for any morbidity and mortality as a result of receiving this vaccine? What is its efficacy against disease? Will it prevent a Covid-19 infection? Will it reduce severity of infection? Will it prevent symptoms in an infected individual? Does it prevent transmission of the disease? Does the vaccine contain the Syncytin-1 protein and if so, when an immunological response to this protein is triggered by the vaccine will this cause male and/or female infertility? 07/01/2021 Disclosed in full
FOI 20/552 10/12/2020 On FLU Vaccines - Which flu vaccination(s) is being administered in the UK since the beginning of 2020. The date(s) on which they started administering the vaccine(s) and (if applicable) ended giving these vaccine(s) or if it is ongoing. - The name of the company that makes the vaccination(s), the name(s) of the vaccination(s) (pharmaceutical and any other names given to the vaccine(s). - Is the vaccine(s) licensed? - government legislated for giving unlicensed flu vaccinations in October (The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 On COVID Vaccines - All vaccines being discussed contain the nanoparticle adjuvant MATRIX-M which is supposed to illicit an immune response. As someone with auto-immune disease (T1 diabetic for 32 years) and thyroid disease I would like to know what studies have been done on this adjuvant and has it been successfully licensed in any other medication? 24/12/2020 Disclosed in full
FOI 20/554 10/12/2020 Please could you let me know whether any safety studies have been carried out on the UK flu vaccine and its interaction with prescription medication such as anti-depressants. 31/12/2020 Disclosed in full
FOI 20/555 14/12/2020 Thank you for your response, ideally could we have the amounts imported/number of packs rather than just the items. 11/01/2021 Disclosed in full
FOI 20/556 09/12/2020 Request relevant licences are those numbered 17490 and 18511 for Myriad Medical Supplies Limited and G P Supplies Limited respectively. 06/01/2021 Disclosed in full
FOI 20/557 08/12/2020 5. Is MHRA considering/assessing/in discussion with companies about any more TA for Covid-19 Products? 24/12/2020 Disclosed in full
FOI 20/558 14/12/2020 A full list of all of the tests that can be conducted on human blood, fluids or body tissues to determine the identity of an individual virus, which is causing or has caused adverse symptoms in that persons. 14/01/2021 Not held
FOI 20/559 04/12/2020 Can you please confirm that the vaccine has an active component and is not just water. And how you have confirmed this and what method has been used. Can you explain how the vaccine with be administered in a sterile manner. Can you please explain why you have given approval to an experimental vaccine and there reasoning why you have granted approval. Also why no one is liable if anything happens. 15/01/2020 Disclosed in full
FOI 20/560 15/12/2020 I have just called your customer service department to ask about funding from the BIll and Melinda Gates Foundation. How much was received? When was received and for what purpose? 12/01/2021 Disclosed in full
FOI 20/561 - No longer FOI Not set Not set Not set Not set
FOI 20/562 07/12/2020 It is my understanding Cytodyne will be submitting its Biologics License Application (BLA) for Leronlimab as a combination therapy for multi-drug resistance HIV patients in the UK in the coming weeks. I humbly beg, in the interests of the whole world, that you give CYTODYN’s Leronlimab drug EUA approval immediately 24/12/2020 Not released
FOI 20/563 21/12/2020 1. All of the trials exclude the obese (above 30 BMI). These are one of the groups affected to a larger extent by the virus which is important in that 28.7% of people in the UK are obese. What is the effectiveness of the vaccine amongst those who are obese? 2. Only 10% of people in the trial had a comorbid condition. Yet COVID does tend to occur with those who have a comorbidity (81% of people who died had another condition (https://www.maciverinstitute.com/2020/07/81-of-people-who-died-of-covid-19-had-comorbidities-or-another-underlying-health-condition/). What is the effectiveness of the vaccine amongst those who are primarily affected by the virus namely those who have a comorbid condition? 3. The LD/SD trial consisted of a lower proportion of ethnic minorities than is the case amongst the population (the proportion of people who are from ethnic minorities in the UK is 12.9% whereas the proportion of people from ethnic minorities in trial is 8%) and completely excludes those over 55 (along with the obese). What is the effectiveness of the vaccine amongst ethnic minorities? 4. The SD/SD trials both use an unrepresentative age range. The proportion of people over the age of 55 in Brazil is 19% of the population yet only 9.5% of people in the trial are over 55.The proportion of people over the age of 55 in the UK is 30% of the population yet only 21% of people in the trial are over 55. What is the actual effectiveness of the vaccine amongst in a group who is primarily affected, namely those over 55? 5. The gender in this instance is important in that, there are far more women in the trial than men. Men are more greatly affected by COVID. What is the effectiveness of the vaccine amongst men? 6. The above data only pertains to symptomatic infections. For asymptomatic infections however, the results show that the effectiveness is worse in that, according to the lancet, vaccine efficacy of 4% for those given two full doses, and of 59% in those given a half then a full dose according to findings which need to be confirmed (https://www.maciverinstitute.com/2020/07/81-of-people-who-died-of-covid-19-had-comorbidities-or-another-underlying-health-condition/). If one can believe reports in the media, 80% of those affected are asymptomatic carriers (https://www.aa.com.tr/en/europe/over-85-of-virus-patients-in-uk-asymptomatic-study/2000300) What is the effectiveness with respect to asymptomatic infections? 05/01/2021 Disclosed in full
FOI 20/564 21/12/2020 A complete list of all available peer reviewed evidence and complete evaluations of testing protocols for all and any Lateral Flow Devices, including the Innova SARS-CoV-2 Antigen Rapid Qualitative Test, currently being used to determine the infection rate of SARS – CoV-2 with or without symptoms, in the British public, which conclusively demonstrate the sensitivity, specificity and robust ability of the Testing regime and the results obtained. 11/01/2021 Not held
FOI 20/565 10/12/2020 Does the MHRA not believe that during a pandemic you should use what works until something better comes along? When is the MHRA going to recommend Ivermectin treatment for COVID-19? It is now common knowledge that the Pfizer/NBioTech vaccine that has been rushed through your approval process cannot prevent anyone vaccinated from becoming infected or from becoming infectious. In fact, it is proving to be dangerous to the health of many people. Ivermectin is proven to be an effective and inexpensive preventative treatment; a treatment for early, post exposure and severe case treatment for Covid-19. Have people not died and are people not dying because of MHRA's lack of action? 29/12/2020 Disclosed in full
FOI 20/566 18/12/2020 In relation to the clinical trials supporting the temporary authorisation of Vaccine BNT162b2 (medicinal product “COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection”) granted to Pfizer/BioNTech, please provide me with the individual cycle threshold values used during the Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test for each of the 8 confirmed COVID-19 cases in the COVID-19 mRNA Vaccine group and 162 confirmed COVID-19 cases in the placebo group, as referred to in Section 5.1 Pharmacodynamic properties of the REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS document. 13/01/2021 Not held
FOI 20/568 20/12/2020 Request for Information (attached for your reference) ADR follow up questionnaires for Deferasirox RMP from MHRA. Request for Information (As per CMDh list attached for your reference) ADR follow up questionnaires for Lacosamide RMP from MHRA. 21/01/2021 Disclosed in full
FOI 20/569 11/12/2020 Under the freedom of information act please can you provide me with all the details and information you hold that was used to determine how the Pfizer covid 19 vaccine was safe and effective to be used and granted a licence to be used in an emergency.if this was decided by a vote please provide the names who voted and how they voted .many thanks d.japes 04/01/2021 Disclosed in part
FOI 20/570 21/12/2020 Do you currently have any AI enabled chatbots engaging with Citizens directly? If not, do you intend to introduce this in the next 12 months? If you are looking to introduce AI enabled chatbots in the next 12 months, then please advise us on who is best to contact regarding this. (Name, Job Title and Email address)  08/01/2021 Disclosed in full
FOI 20/571 03/12/2020 I understand why we have had to rush the Covid vaccines through testing as quickly as possible, but how can we be certain that the vaccine isn’t going to cause some much greater issue for recipients? All things come with some level of risk, and it is inevitable that we will find a small proportion of people suffer adverse side-effects, possibly catastrophic side-effects. But how can we be certain that we aren’t inadvertently causing some adverse response in the majority? 23/12/2020 Disclosed in full
FOI 20/572 23/12/2020 Could you forward to me statistic details or reaction and mortality rates die to the vaxines being used to inoculate against covid19 . 1 - all reactions within 7 days of 1st injection 2 - all reactions within 7 days of the 2nd injection 3 - all mortalities reported within 7 days or the 1st injection . 4 - all motalities reported within 7 days of the 2nd injection 5 - the number of people vaxinated with the 1st injection 6 - the number of people vaxinated with the 2nd injection 26/01/2021 Not held
FOI 20/573 22/12/2020 Can you please release the true accuracy of the PCR test for detecting Covid-19 (not including other strains of coronavirus) just solely Covid-19. How accurate is test in determining whether or not the people who've been tested have had Covid-19? 08/01/2021 Not held
FOI 20/574 17/12/2020 Why is this potential for serious harm not listed in your leaflet as a possible side effect? 2. The mRNA nano-particles (active ingredients) are coated with PEG. The development of auto-antibodies to polyethylene glycol (PEG) will not only make the vaccine less effective but may cause allergic reactions with deadly adverse events. Why is this potential for serious harm not listed in your leaflet as a possible side effect? What scientific evidence does MHRA have that deems PEG safe for injection which is not the same as it being eaten? 3. The vaccines also contain mNeonGreen, an ingredient not listed in your leaflet. This has bio-luminescent properties. Why is this ingredient, taken from marine invertebrates, being used in the vaccines? 4. Why does your leaflet not make it clear that the vaccine will not prevent recipients from being infected with SARS CoV-2 thus becoming infectious? 5. The American NIH published a list of potential ADRs that includes Guillain Barre Syndrome, Transverse Myelitis, Encephalitis, Stroke, Arthritis and even Death among other conditions. Does the MHRA have evidence that such side effects will not occur? If not, why do these do not appear in your leaflet? 6. Is the MHRA not aware that the approach of vaccinating people with experimental mRNA vaccines violates the precautionary principle, which requires that a medical intervention be proven safe before being released. How can the omission of extended trials deem them safe? 7. If it is known that the product may cause harm, and especially death, in advance and is still released without the public being fully informed of these risks, does this not constitute an egregious violation of the medical ethical principles established through the Nuremberg Code in order to prevent human rights violations? 8. if recipients are vaccinated without knowing the potential side effects, how can they give their “informed consent”? 9. It s understood that the Pfizer/BioNTech trial did not include anyone over the age of 55 and anyone with co-morbidities. Why is it therefore deemed appropriate to vaccinate the over 80s first; most of whom will have at least one co-morbidity when the risks to them are unknown? (If this is a political question it may be more appropriate to ask the DHSC rather than the MHRA). 07/01/2020 Disclosed in full
FOI 20/575 18/12/2020 In light of international studies and research that indicate positive outcomes, the American Medical Association has rescinded its statement that doctors should be prevented from prescribing Hydroxychloroquine (HCQ). The AMA’s new position is that doctors must be permitted to use their judgment about how to treat Covid patients. In light of international studies and research, when will the MHRA review their policy and permit UK doctors to use their judgment about how to treat Covid patients? 08/01/2021 Disclosed in full
FOI 20/576 23/12/2020 Also please provide me a certified list of all ingredients of the Pfizer vaccine. Please privude me with the contact details of the organisation that has tested the accuracy of the PCR test. Please provide me with the Swine flu vaccine ingredients and if any damages were paid out by the Uk government and if so how much. Please provide me with the scientific Isolation document of the Swine flu. Please advise when the Swine flu vaccine was removed from the market and why. 04/01/2021 Disclosed in full
FOI 20/577 29/12/2020 Inspection reports for GxP (GDP and GVP) 26/01/2021 Disclosed in part
FOI 20/578 18/12/2020 Under the freedom of information Act 2000, please provide me with the following 1) Nasal Flu Vaccine Efficacy rates for the past 5 years 2)  Data on yellow card reporting for the nasal flu vaccine for the past 5 years 24/12/2020 Disclosed in full
FOI 20/579 19/12/2020 Jeremy Hunt, then Health Secretary, ordered 2015, an investigation into the care and death of Elizabeth Dixon. Has the MHRA been alerted to the medication overdose and circumstances and the death of the baby, either by the Chair of the investigation, anyone from the investigation team, the NMC or by Hampshire Constabulary who were also fully aware of this during their own investigation and by 2006 at the latest, or by any other organisation or department? 21/01/2021 Disclosed in full
FOI 20/580 29/12/2020 Please can you tell me from the stage 3 results of all Covid vaccines that you have looked at how many of the participants had relapse and remitting MS? If any did, are you able to confirm if the participants were on DMD's to suppress the immune system?Did the injection bring on her relapse or was she given a placebo and it was simply a coincidence? Have there been any significant studies into other medications taken by patients and the effects they have on the vaccine or vice versa? If the medication I am on is so powerful that it stops my relapses, I want to know how it will react with the vaccine's DNA sequencing, which as I understand it is in order to stimulate the immune system, when my immune system is currently dampened down to stop it overreacting and attacking my brain and spinal cord? 13/01/2021 Disclosed in full
FOI 20/581 15/01/2020 Please provide all data you hold relating to any Covid vaccine approved or yet to be approved for any use including any reported or observed adverse effect or side-effect following its administration to human or animal. 31/01/2021 Disclosed in full
FOI 20/582 30/12/2020 How many people in the UK have died of Covid 19 without any underlying Illnesses? Only Covid 19 deaths please 04/01/2021 Not held
FOI 20/583 21/12/2020 I should be most grateful if we could obtain the following documents for the medicinal product "  Fentanyl 50 microgram/ml Injection   ", PL 01502/0062 , MAH: hameln pharma ltd. Clinical Overview, Preclinical Overview, Risk Management Plan, Public Assessment Report. 05/01/2021 Not released
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